Diabetes Mellitus, Type 1NCT06428591
Tandem Freedom Feasibility Study 1
A study testing t:slim X2 insulin pump with Tandem Freedom Algorithm in people with Diabetes Mellitus, Type 1, run by Tandem Diabetes Care, Inc. at 1 site in New Zealand.
Trial summary
This feasibility study is a prospective, single arm study evaluating the Tandem Freedom system in adults with type 1 diabetes. Existing Control-IQ technology users will use Control-IQ technology at home for a 1 week run-in, then will use Tandem Freedom in a supervised hotel setting. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Diabetes Mellitus, Type 1
- What is being tested?
- t:slim X2 insulin pump with Tandem Freedom Algorithm
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteNew Zealand
- Study dates
- 29 May 2024to 10 Jun 2024
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age ≥18 years old
- Diagnosis of type 1 diabetes for at least 1 year
- Current Control-IQ user, having been prescribed Control-IQ for at least 3 months
- HbA1c ≤10%, recorded in the last 3 months
- Investigator has confidence that the participant can successfully operate all study devices and is capable of adhering to the protocol, including performing the weekend hotel observed setting portion of the study.
- Willing to use only aspart (novorapid) or lispro (humalog) insulin with the study pump, with no use of long-acting basal insulin injections, or inhaled insulin with the study pump.
- Have current glucagon product to treat severe hypoglycemia (injectable or nasal) at home (site will provide prescription if they do not have one)
Who cannot join
- More than 1 episode of diabetic ketoacidosis (DKA) in the past 6 months
- More than 1 episode of severe hypoglycemia (needing assistance) in the past 6 months
- Inpatient psychiatric treatment in the past 6 months
- For Female: Currently pregnant or planning to become pregnant during the time period of study participation
- A negative pregnancy test will be required for all females of child-bearing potential
- Counseling on appropriate birth control options will be provided to all females of child-bearing potential
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- Concurrent use of any non-insulin glucose-lowering agent, other than metformin (for example, GLP-1 agonists, Symlin, DPP-4 inhibitors, SGLT-2 inhibitors, sulfonylureas).
- Hemophilia or any other bleeding disorder
- Hemoglobinopathy
- History of heart, liver, lung or kidney disease determined by investigator to interfere with the study
- History of allergic reaction to Humalog or Novorapid
- Use of any medications determined by investigator to interfere with study
- Significant chronic kidney disease (which could impact CGM accuracy in investigator's judgment) or hemodialysis
- Concurrent use of any medication that could interfere with the study CGM, such as hydroxyurea
- History of adrenal insufficiency
- History of abnormal TSH consistent with hypothyroidism or hyperthyroidism that is not appropriately treated
- History of gastroparesis
- A condition, which in the opinion of the investigator or designee, would put the participant or study at risk
- Participation in another pharmaceutical or device trial at the time of enrollment or anticipated for during the time period of study participation
- Employed by, or having immediate family members employed by Tandem Diabetes Care, Inc., or having a direct supervisor at place of employment who is also directly involved in conducting the clinical trial (as a study investigator, coordinator, etc.); or having a first-degree relative who is directly involved in conducting the clinical trial
Trial locations and contacts
1 site in 1 country.
About this study
This feasibility study is a prospective, single arm study evaluating the Tandem Freedom system in adults with type 1 diabetes. Existing Control-IQ technology users will use Control-IQ technology at home for a 1 week run-in, then will use Tandem Freedom in a supervised hotel setting.
Read the detailed description
After a 1 week Control-IQ run-in at home, 10 adults who are existing Control-IQ users with type 1 diabetes will use the Tandem Freedom System for 1 day with boluses, and 1 day without boluses, in a supervised hotel setting. Participants will perform meal and exercise challenges. The primary outcome is safety events. CGM time in ranges will also be evaluated.
- Conditions
- Diabetes Mellitus, Type 1
- Being tested
- t:slim X2 insulin pump with Tandem Freedom Algorithm
- Keywords
- type 1 diabetes, T1D, Tandem, t:slim X2, automated insulin delivery
- Medical subject headings
- Diabetes Mellitus, Type 1
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
t:slim X2 insulin pump with Tandem Freedom AlgorithmDevice
Participants will use the Tandem Freedom system for one day with insulin boluses and one day without insulin boluses.
| Study group | Role | What they receive |
|---|---|---|
| Tandem Freedom | Experimental | After a one week run-in period with Control-IQ technology, participants used the Tandem Freedom system for one day with insulin boluses and one day without insulin boluses.
Participants performed meal and exercise challenges in a supervised hotel setting. Receives: Device: t:slim X2 insulin pump with Tandem Freedom Algorithm |
What is being measured
The primary outcome is the main question the study is designed to answer.
Severe Hypoglycemia Events
Number of severe hypoglycemia events (with cognitive impairment such that assistance of another individual is needed for treatment)
Measured: Control-IQ Run-in with boluses 7 days, day 8 freedom with meal bolus and day 9 freedom without meal bolus
Diabetic Ketoacidosis Events
Number of diabetic ketoacidosis events
Measured: Control-IQ Run-in with boluses 7 days, day 8 freedom with meal bolus and day 9 freedom without meal bolus
Secondary outcomes (9)
Percent Time <54 mg/dL
CGM measured percent time <54 mg/dL
Measured: Control-IQ Run-in with boluses 7 days, day 8 freedom with meal bolus and day 9 freedom without meal bolus
Percent Time <70 mg/dL
CGM measured percent time <70 mg/dL
Measured: Control-IQ Run-in with boluses 7 days, day 8 freedom with meal bolus and day 9 freedom without meal bolus
Percent Time in Range 70 - 180 mg/dL
CGM measured percent time in range 70 - 180 mg/dL
Measured: Control-IQ Run-in with boluses 7 days, day 8 freedom with meal bolus and day 9 freedom without meal bolus
Percent Time in Range 70 - 140 mg/dL
CGM measured percent time in range 70 - 140 mg/dL
Measured: Control-IQ Run-in with boluses 7 days, day 8 freedom with meal bolus and day 9 freedom without meal bolus
Percent Time >180 mg/dL
CGM measured percent time >180 mg/dL
Measured: Control-IQ Run-in with boluses 7 days, day 8 freedom with meal bolus and day 9 freedom without meal bolus
Percent Time >250 mg/dL
CGM measured percent time >250mg/dL
Measured: Control-IQ Run-in with boluses 7 days, day 8 freedom with meal bolus and day 9 freedom without meal bolus
Mean Glucose (mg/dL)
CGM measured mean glucose (mg/dL)
Measured: Control-IQ Run-in with boluses 7 days, day 8 freedom with meal bolus and day 9 freedom without meal bolus
Glucose Coefficient of Variation (%)
CGM measured Coefficient of Variation (%)
Measured: Control-IQ Run-in with boluses 7 days, day 8 freedom with meal bolus and day 9 freedom without meal bolus
Glucose Standard Deviation (mg/dL)
CGM measured Standard Deviation (mg/dL)
Measured: Control-IQ Run-in with boluses 7 days, day 8 freedom with meal bolus and day 9 freedom without meal bolus
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 May 2024
- Study start29 May 2024
- Primary completion10 Jun 2024
- Study completion10 Jun 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Diabetes Mellitus, Type 1Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- Tandem Diabetes Care, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Jordan Pinsker, MD, Study director, Tandem Diabetes Care
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06428591
- Sponsor's protocol ID
- TP-0017517
- Other IDs
- U1111-1307-6267
- Status last verified
- Nov 2025
- First submitted
- 20 May 2024
- Last updated
- 18 Nov 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Tandem Freedom Feasibility Study 1
- ClinicalTrials.gov ID
- NCT06428591
- Acronym / sponsor ID
- TP-0017517
- Conditions
- Diabetes Mellitus, Type 1
- Keywords
- type 1 diabetes, T1D, Tandem, t:slim X2, automated insulin delivery
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- Tandem Diabetes Care, Inc.Industry (pharma, biotech, devices)
- Study start
- 29 May 2024 (actual)
- Primary completion
- 10 Jun 2024 (actual)
- Study completion
- 10 Jun 2024 (actual)
- First posted
- 24 May 2024 (actual)
- Results
- Posted 18 Nov 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This feasibility study is a prospective, single arm study evaluating the Tandem Freedom system in adults with type 1 diabetes. Existing Control-IQ technology users will use Control-IQ technology at home for a 1 week run-in, then will use Tandem Freedom in a supervised hotel setting.
Detailed description
After a 1 week Control-IQ run-in at home, 10 adults who are existing Control-IQ users with type 1 diabetes will use the Tandem Freedom System for 1 day with boluses, and 1 day without boluses, in a supervised hotel setting. Participants will perform meal and exercise challenges. The primary outcome is safety events. CGM time in ranges will also be evaluated.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Tandem Freedom | Experimental | Device: t:slim X2 insulin pump with Tandem Freedom AlgorithmAfter a one week run-in period with Control-IQ technology, participants used the Tandem Freedom system for one day with insulin boluses and one day without insulin boluses. Participants performed meal and exercise challenges in a supervised hotel setting. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Age ≥18 years old
- Diagnosis of type 1 diabetes for at least 1 year
- Current Control-IQ user, having been prescribed Control-IQ for at least 3 months
- HbA1c ≤10%, recorded in the last 3 months
- Investigator has confidence that the participant can successfully operate all study devices and is capable of adhering to the protocol, including performing the weekend hotel observed setting portion of the study.
Key exclusion criteria (20 listed)
- More than 1 episode of diabetic ketoacidosis (DKA) in the past 6 months
- More than 1 episode of severe hypoglycemia (needing assistance) in the past 6 months
- Inpatient psychiatric treatment in the past 6 months
- For Female: Currently pregnant or planning to become pregnant during the time period of study participation
- Concurrent use of any non-insulin glucose-lowering agent, other than metformin (for example, GLP-1 agonists, Symlin, DPP-4 inhibitors, SGLT-2 inhibitors, sulfonylureas).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| t:slim X2 insulin pump with Tandem Freedom AlgorithmParticipants will use the Tandem Freedom system for one day with insulin boluses and one day without insulin boluses. | Device | Tandem Freedom |
Primary outcome
Severe Hypoglycemia Events
Time frame: Control-IQ Run-in with boluses 7 days, day 8 freedom with meal bolus and day 9 freedom without meal bolus
Number of severe hypoglycemia events (with cognitive impairment such that assistance of another individual is needed for treatment)
Diabetic Ketoacidosis Events
Time frame: Control-IQ Run-in with boluses 7 days, day 8 freedom with meal bolus and day 9 freedom without meal bolus
Number of diabetic ketoacidosis events
9 secondary outcomes
Percent Time <54 mg/dL
Time frame: Control-IQ Run-in with boluses 7 days, day 8 freedom with meal bolus and day 9 freedom without meal bolus
Percent Time <70 mg/dL
Time frame: Control-IQ Run-in with boluses 7 days, day 8 freedom with meal bolus and day 9 freedom without meal bolus
Percent Time in Range 70 - 180 mg/dL
Time frame: Control-IQ Run-in with boluses 7 days, day 8 freedom with meal bolus and day 9 freedom without meal bolus
Percent Time in Range 70 - 140 mg/dL
Time frame: Control-IQ Run-in with boluses 7 days, day 8 freedom with meal bolus and day 9 freedom without meal bolus
Percent Time >180 mg/dL
Time frame: Control-IQ Run-in with boluses 7 days, day 8 freedom with meal bolus and day 9 freedom without meal bolus
Percent Time >250 mg/dL
Time frame: Control-IQ Run-in with boluses 7 days, day 8 freedom with meal bolus and day 9 freedom without meal bolus
Mean Glucose (mg/dL)
Time frame: Control-IQ Run-in with boluses 7 days, day 8 freedom with meal bolus and day 9 freedom without meal bolus
Glucose Coefficient of Variation (%)
Time frame: Control-IQ Run-in with boluses 7 days, day 8 freedom with meal bolus and day 9 freedom without meal bolus
Glucose Standard Deviation (mg/dL)
Time frame: Control-IQ Run-in with boluses 7 days, day 8 freedom with meal bolus and day 9 freedom without meal bolus
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Nov 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jordan Pinsker, MD study director
Tandem Diabetes Care
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing t:slim X2 insulin pump with Tandem Freedom Algorithm in people with Diabetes Mellitus, Type 1, run by Tandem Diabetes Care, Inc. at 1 site in New Zealand.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 20 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in New Zealand. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 18 Nov 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Severe Hypoglycemia Events (time frame: Control-IQ Run-in with boluses 7 days, day 8 freedom with meal bolus and day 9 freedom without meal bolus). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Nov 2025.